Halozyme Announces FDA Approval of Roche's Tecentriq Hybreza™ With ENHANZE® for ...
Halozyme announces FDA approval for Tecentriq Hybreza™, a subcutaneous anti-PD-(L)1 immunotherapy using ENHANZE® technology, reducing injection time to 7 minutes from 30-60 minutes for IV infusion, available for adult indications of IV Tecentriq®.
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FDA approves Roche’s subcutaneous Tecentriq Hybreza, offering quicker and more comfortable cancer immunotherapy. Administered in 7 minutes, it covers all Tecentriq IV indications, with comparable safety and efficacy. Patient preference for Hybreza is strong, citing reduced clinic time and increased comfort.
Halozyme announces FDA approval for Tecentriq Hybreza™, a subcutaneous anti-PD-(L)1 immunotherapy using ENHANZE® technology, reducing injection time to 7 minutes from 30-60 minutes for IV infusion, available for adult indications of IV Tecentriq®.
Roche's Tecentriq Hybreza, using Halozyme's ENHANZE tech, received FDA approval for subcutaneous administration in 7 mins, vs. 30-60 mins IV infusion. Available for all adult IV Tecentriq indications, including lung, liver, skin, and soft tissue cancers. Combines atezolizumab with rHuPH20 enzyme.
Roche received FDA approval for OCREVUS ZUNOVO™, a subcutaneous formulation of ocrelizumab with Halozyme's ENHANZE® technology, for treating RMS and PPMS. The 10-minute SC injection offers treatment flexibility and optionality, supported by Phase III OCARINA II trial data showing non-inferior OCREVUS levels and comparable safety/efficacy to IV formulation.
The FDA approved Roche's subcutaneous formulation of Tecentriq, branded as Tecentriq Hybreza, making it the first SC anti-PD-(L)1 cancer immunotherapy in the U.S. The SC option reduces treatment time to about 7 minutes compared to 30-60 minutes for IV infusion and is available for all Tecentriq indications.
Halozyme Therapeutics announces FDA approval for Roche's Tecentriq Hybreza, a subcutaneous combination of atezolizumab and Halozyme's Enhanze technology, offering faster administration and expanded availability in the US.
FDA approves first injectable immune checkpoint inhibitor, Tecentriq Hybreza, reducing administration time to 7 minutes from 30-60 minutes for IV infusions. Approved for same indications as Tecentriq infusions, it uses Enhanze technology for rapid dispersion. Based on IMscin001 trial, drug levels and safety profiles were similar to IV formulation. 71% preferred injectable version for less clinic time and increased comfort.
The FDA approved Genentech’s Tecentriq Hybreza, the first PD-(L)1 inhibitor for subcutaneous administration, reducing injection time to about 7 minutes from 30-60 minutes for IV infusion. Tecentriq Hybreza combines Tecentriq with Halozyme’s Enhanze drug delivery technology, offering comparable efficacy and safety to the IV formulation, with 71% of patients preferring it for reasons like reduced clinic time and emotional distress.
FDA approves Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy, offering faster treatment and more accessible settings for patients with various cancers.
FDA approves subcutaneous versions of Roche's biologic drugs: Tecentriq Hybreza for cancer (7-min injection, 3.8B Swiss francs revenue) and Ocrevus Zunovo for MS (10-min injection, 6.4B Swiss francs revenue), both offering faster dosing times and broader accessibility.
Halozyme announces FDA approval for Roche's Tecentriq Hybreza™, a subcutaneous anti-PD-(L)1 immunotherapy using ENHANZE® technology, offering faster administration and broader treatment options for lung, liver, skin, and soft tissue cancers.
FDA approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for subcutaneous injection, covering all approved indications of intravenous atezolizumab. Based on IMscin001 trial data, Tecentriq Hybreza showed comparable atezolizumab exposure, ORR, PFS, and OS to intravenous atezolizumab, with common adverse reactions including fatigue and musculoskeletal pain. Supplied in a single-dose vial, it is administered subcutaneously into the thigh.
FDA approves Genentech’s Tecentriq Hybreza, the first subcutaneous anti-PD-(L)1 cancer immunotherapy, offering treatment flexibility with a 7-minute injection compared to 30-60 minutes for IV infusion. Available for various cancer types, it maintains safety and efficacy similar to IV Tecentriq.
FDA approves Tecentriq Hybreza, a subcutaneous PD-(L)1 inhibitor, offering a seven-minute injection option for various cancers, mirroring IV Tecentriq's safety and efficacy.
FDA approves Tecentriq Hybreza, the first PD-(L)1 inhibitor for subcutaneous injection, offering faster treatment (approx. 7 mins) compared to IV infusion (30-60 mins) with consistent safety and efficacy. Available for various cancer types, it provides greater treatment flexibility and patient preference.
FDA approves first subcutaneous anti-PD-L1 cancer immunotherapy, atezolizumab and hyaluronidase-tqjs, for same adult indications as IV atezolizumab, with treatment time reduced to 7 minutes.
Roche received FDA approval for OCREVUS ZUNOVO™, a subcutaneous injection using Halozyme's ENHANZE® technology for RMS and PPMS, offering a 10-minute, twice-a-year treatment.
FDA approves Roche’s Tecentriq Hybreza, the first subcutaneous PD-L1 inhibitor, offering a 7-minute SC injection vs. 30-60 minute IV infusion. Studies show comparable safety, efficacy, and patient preference for SC form, with 71% preferring it over IV.
FDA approves Roche's Tecentriq Hybreza™, a subcutaneous anti-PD-(L)1 immunotherapy using Halozyme's ENHANZE® technology, reducing injection time to 7 minutes from 30-60 minutes for IV infusion, available for adult indications of IV Tecentriq® in the U.S.
FDA approves Roche's OCREVUS ZUNOVO™ with Halozyme's ENHANZE® for RMS and PPMS, offering a 10-minute subcutaneous injection.